PTS Pulse Q2 2023

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pulse Q2

PTS June 2023 Blog header

Employee Connection:
Engineers are the Oil in the PTS Machine

At PTS Diagnostics, we rely on a group of multi-faceted engineers to keep our operations running smoothly and to ensure that we deliver the highest quality products. This talented team— comprised of operations engineers, software engineers, mechanical engineers, validation specialists, scientists, and interns—is a driving force behind our company’s success.

When it comes to problem-solving, the engineering teams at PTS leave no stone unturned. During brainstorming sessions, they encourage a free flow of ideas, welcoming even the most unconventional suggestions. From exploring potential failures to considering out-of-the-box solutions, these collaborative discussions fuel their innovation engine. By fostering an environment that promotes creativity, our engineers thrive and continually push the boundaries of what’s possible.

Our group of operations engineers and machinists is led by David Gloudemans. From managing manufacturing and process operations, to ensuring equipment maintenance, David’s team keeps our production lines running smoothly and diligently crafts precision parts for our operations in both Whitestown and Sunnyvale branches.

Our sustaining engineering team, led by Steve Zucker, focuses on optimizing product performance, particularly the intricate interaction between our PTS Panels test strips and CardioChek Plus analyzers. This cross-functional dream team brings together a diverse range of engineering disciplines, such as chemistry, software development, mechanical design, validation, along with the fresh perspectives of our enthusiastic interns.

A remarkable amount of overlap and synergy exists between David’s and Steve’s teams. The seamless integration of these engineering specialties ensures that we deliver nothing short of excellence. Together, they tackle complex questions and challenges that demand the collective knowledge and experience of both groups. It is through this collaboration that solutions are found, and our products continue to exceed expectations.

In the past couple of years, the engineering teams have helped us to successfully overcome a wide range of complex challenges. To name a few:

  • They spearheaded the transformation and successful launch of CardioChek Plus v1.12— an impressive user interface upgrade driven by customer feedback.
  • They led the efforts to modify the battery door on our CardioChek analyzers, which required extensive input from multiple team members and meticulous analysis of field events. With the FDA’s approval being a prerequisite for any changes we make, the project required a seamless collaboration between our engineers and regulatory experts. In the end, the teams devised a novel mold design and introduced a practical ribbon feature, facilitating easier battery removal. Accomplishments like these exemplify our unwavering commitment to continuous improvement.
  • Our engineering teams also have faced the critical challenge of IVDR certification. Meeting the new requirements demands rigorous documentation, comprehensive understanding, and exhaustive testing.
  • Over the past year, they have made significant progress in improving yields in the automation process. This ensures that our products are made in a high-quality manner and delivered on time.
  • Currently, they are successfully executing the duplication of the A1C processes at PTS Whitestown. This includes mixing chemicals and applying them to substrates, cutting and slitting materials, making samplers, making cartridges, programming monitors, qualifying printer equipment, and more. The engineers also modelled the capacity needs for 2023/2024 and the future.
  • The maintenance and machinist group produces components that are obsolete and can’t be purchased off the shelf. Their quick response has saved both facilities from begin down for long periods of time. They also are partners in the tooling development.
  • They are the process technical resources and are the first line of defense in troubleshooting and making improvements to existing equipment. And, they do all of this while supporting the production floor.

In 2023 and beyond, our engineers continue to tackle thorny problems and set ambitious goals. Two key objectives they are currently working on are the duplication of A1CNow manufacturing at The Whitestown facility and the smooth launch of a new lipid panel test strip formulation.

Thanks, PTS engineers, for lending your considerable talents to PTS Diagnostics!

FARMacy West Virginia Prescription for Produce Program:

Transforming Health through Nutrition

In a state plagued by poor health statistics, Carol Antonelli- Greco, a dedicated family physician in Wheeling, West Virginia, recognized the need to address the underlying issues contributing to prevalent health conditions like diabetes, hypertension, and obesity. Through partnerships with the West Virginia University Extension Office, urban farming group Grow Ohio Valley, and local health clinics, she founded the FARMacy West Virginia Prescription for Produce Program in 2016.

FARMacy photo

By prescribing produce to patients, the program bridges the gap between farmers and individuals with chronic disease who are in need, ensuring a direct exchange of fresh, locally grown food. This innovative approach aims to promote better health outcomes by addressing the root causes of chronic diseases through nutrition and culinary knowledge.

The program directors have also worked closely with the WVU School of Public Health’s Office of Health Services Research to standardize the collection of program participants’ health data so that they could report on the impacts of the program on a statewide level. Some of the data collected came from our very own A1CNow+ test system!

The transformative power of the FARMacy program is evident both through the data, and through the stories of individuals who have experienced positive changes in their health and lifestyle. Participants reported weight loss, improved blood pressure, better kidney function, and normalized blood work results. Preliminary data shows that participants experienced a 0.9% decrease in A1C, on average.

Understanding the significance of personal connections in patient care, the FARMacy program goes beyond providing healthy food. Local WVU extension staff members played a pivotal role in educating patients during produce pickups. By offering written materials, sharing recipes, and engaging in one-on-one conversations, she ensured that patients received the necessary support and guidance to make informed decisions about their health. This personalized approach fostered trust, empowerment, and a sense of accountability, encouraging patients to take control of their well-being.

By replacing unhealthy food choices with fresh produce, individuals realized that making small, sustainable changes in their diet and exercise routines can have significant and lasting impacts on their overall well-being.

It is programs like FARMacy that give our work meaning. As a PTS employee you played a small, but important role in providing greater access to care for people with diabetes and heart disease risk factors in West Virginia!

To learn more about the FARMacy Program you can watch a short documentary here: https://youtu.be/Sf8AVddVZkg

Product Highlight:
PTS Scientists Co-Author Published Research By Latasha Little, Product Labeling Manager

3D Model render
(a) 3D model structure of the oxygen insensitive enzyme that was developed in this project.

As a PTS employee, you may already know that triglycerides are an important biomarker of various diseases, including hyperlipidemia. But you may not have known (until now) that two PTS Diagnostics scientists, Gary Hughes and Adrianna Scheller, have recently published a journal article about the development of an enzyme that may be used in future electrochemical measurement methods for analytes like triglycerides. We asked Gary and Adrianna a few questions to help us better understand their work and its implications.

How did you both get involved in this research project?

  • Adrianna: When I joined PTS, the research project was already ongoing. Gary asked if I could get involved and perform some experiments to help finalize the project.
  • Gary: Dr. Aniruddha Patwardhan first met Dr. Sode at the Diabetes Technology Meeting when presenting our poster on the recently released CardioChek Plus (2014). We started having a discussion on his research, and I kept running into him at this and other conferences and eventually collaborated on this project starting in 2019.

What question or challenge was the research setting out to address?

  • The research project addressed the lack of oxygen insensitive enzymes utilized to detect triglycerides electrochemically.

Please explain the goals/findings for the research.

  • The aims of the research project were to develop an oxygen insensitive enzyme capable for use in the development of an electrochemical triglyceride sensor.

What are the possible real-world applications?

  • The real-world applications of this research project include the development of potential triglyceride / lipid panel assays that only require a fingerstick volume worth of blood.

Why is it important?

  • Current triglyceride / lipid panel assays typically require a larger volume of blood and could benefit from improved sensitivity, accuracy, and precision.
Au IDE graphic
(b )Example of a gold (Au)-interdigitated electrode (IDE) electrochemical test strip that was used throughout this project.

What were your roles in the project? Briefly explain.

  • Adrianna: I helped finalize the project by developing calibration curves for triglyceride detection in serum.
  • Gary: Initially, I coordinated getting sensors and materials to the team. After the enzyme was developed, I was able to conduct experiments and helped with editing the manuscript.
Current Chart Graphic
(c) Calibration curve of electrochemical glycerol 3-phosphate (Glp) measurement using the enzyme (a) within the formulary on the IDE electrodes (b). Measuring Glp is a preliminary step in measuring triglycerides.

What was your favorite aspect of the project?

  • Adrianna: My favorite aspect of this project was getting to see the collaboration between an industry company such as PTS and an academic professor such as Dr. Sode. Last year I graduated from graduate school where I performed academic research every day and now, I have worked at PTS doing industrial research, so I enjoyed how this project connected to two together.
  • Gary: Much of the initial research was done during the middle of the pandemic, so just reaching the finish line was thrilling. Also, doing that first experiment with the new enzyme and realizing the immense potential this could have was super exciting.

Does this research have any connection to PTS products?

  • R&D undertakes these types of collaborative initiatives in an effort to identify new materials and/or technologies for future potential development projects. This research in particular could be beneficial for potential triglyceride lipid panel projects in the future.

Read the full research paper here:

https://ptsdiagnostics.showpad.com/share/1McpBSzy8uRvPDRT45gmK

PTS Employee Spotlights

Cliffe Allen
Vice President, US Sales

Cliffe Allen group photo

When did you join PTS?
2015

Name three hashtags that describe you.
#ProudDad #FigureItOut #PositiveOutlook

Favorite place to “get away”.
Any golf course, especially new ones, and most importantly, with good friends. I’m lucky to have a group of close friends that like to golf also. That is like therapy to me.

Best part about your job at PTS?
The people I work with every day. From the internal PTS
departments to the people on our sales team. We all are rowing in the same direction, with the same purpose. It is inevitable that the rowing gets out of sync from time to time, but we always figure out how to get back into a rhythm.

Do you have a secret talent? What is it?
I’m a pretty decent basketball player, and still play twice a week.

One thing you can’t resist?
DQ Blizzards, especially the Chocolate Extreme.

Best advice you have ever been given?
Everything happens for a reason—it’s always true, sometimes it just takes a while to figure out the reason.

Abbey Braasch
HR Generalist

Abbey Braasch and child
When did you join PTS?
March 2023

Name three hashtags that describe you.
#Empathetic #Achiever #Developer

Favorite place to “get away”.
Hocking Hills! I love all trails though – please give me some recommendations 🙂

What do you like best about working at PTS?
Having a father who had diabetes and passed at a young age, I love knowing that PTS is making a HUGE difference in the lives of so many!

Best part about your job at PTS?
The awesome people I get to meet and interact with daily! PTS is filled with so many great individuals and I’m happy I get to work alongside each one.

Do you have a secret talent? What is it?
I survived growing up with 7 siblings (6 of them being older than I am), and still tolerate them to this day.

One thing you can’t resist?
Early morning cuddles with my 6-year-old. Great start to my day!

Best advice you have ever been given?
Be fearless in the pursuit of what sets your soul on fire.

Kyle Nelson
Inside Sales Specialist

Kyle Nelson Headshot

When did you join PTS?
March 2022

Name three hashtags that describe you.
#Funny #Social #Caring #Honest

Favorite place to “get away”.
Nature. The woods and rivers are my happy place.

Best part about your job at PTS?
I enjoy traveling to trade shows and learning more about how our devices make a difference in the medical environment. I enjoy meeting and speaking with people from various backgrounds who are all committed to improving the lives of those around them.

Favorite part about working at PTS?
What I like best about working at PTS is the close-knit community here. Everyone has been very welcoming and made me feel like a part of the team.

Do you have a secret talent? What is it?
Massage Therapy.

One thing you can’t resist?
BBQ especially ribs.

Best advice you have ever been given?
Treat others as you would like to be treated.

Alex Bridges
Senior Controls and Systems Engineer

Alex Bridges and Dog

When did you join PTS?
July 25, 2022

Name three hashtags that describe you.
#BoardGameEnthusiast #NewDad #Pleasant

Favorite place to “get away”.
I love the Rocky Mountains. Skiing, Hiking, Camping, Snowshoeing, or just lounging in a cabin are the best ways to put me at ease.

Best part about your job at PTS?
I’m the kind of person who enjoys variety and puzzle solving in my daily responsibilities. The best part of my job is all the different kinds of problems I get asked to help out with. It feels great to finally arrive at a complete answer to a tough question with a grateful coworker.

Favorite part about working at PTS?
The people I get to work with here are truly remarkable! It is so rare to have such a capable, compassionate, and creative group of coworkers. The excellent team here makes coming to work so much easier.

Do you have a secret talent? What is it?
I’ve been working on coin flipping tricks. I’m not very good, but it’s a nice way to keep my hands occupied.

One thing you can’t resist?
Fresh Mango. I’m almost glad they don’t grow well here, because I would probably eat only mangoes for the rest of my life if I had access to a tree.

Best advice you have ever been given?
Take everything one step at a time. If something feels too hard, you are trying to take too big of a step.

HR Corner:

Cog Wheels

It’s BASEBALL SEASON!
Indianapolis Indians Tickets Available (Whitestown)!

PTS has season tickets for Indianapolis Indians tickets for home games hosted at Victory Field downtown Indianapolis. We have four tickets for each game, which are available for any interested employee. The Indians schedule can be found here: https://www.milb.com/indianapolis/schedule/2023-04

Tickets are distributed first come, first serve. Please visit the HR office to see available dates, sign up, and receive your tickets! PLAY BALL!!!

Also, Join us Friday, July 28 for for PTS Family Day at the Indianapolis Indians Game. Stay tuned for more details.

Safety Team News

2023 Noise Survey: Personal noise exposure testing was conducted at our Whitestown Facility to establish a noise exposure baseline for the manufacturing areas:

  • Manual Strip Production
  • Chemical Production
  • Automated Strip Production

We are pleased to inform you that we remain compliant with Federal and Local Hearing Conservations Regulations. We are delighted to confirm that we have a safe and healthy work environment for our PTS family. Specific results can be obtained from Sarah Chavez, Environmental Health and Safety Manager at [email protected].

As always, please let any of the Safety Team members know of any safety/health concerns or recommendations.

 

Cog WheelsA Message from Jonathan Chapman, President & CEO

Dear All,

I wanted to let you know that PTS Diagnostics has received the official letter from Gina Brackett, Director, Compliance Branch at the US Food and Drug Administration confirming that the FDA has completed its verification of PTS’ corrective actions in response to the 2019 Warning Letter. The FDA has concluded that PTS has adequately addressed the violations that were identified.

As you know, it has been a long road for PTS that has involved a very thorough overhaul of the Company’s QMS and a great deal of time and effort to undertake numerous remediation activities. Although it has been a painful chapter in the Company’s history, it is nevertheless coming out of it a stronger, more robust company, better positioned to meet the opportunities presented by the market.

The response to remediate the issues identified in the Warning Letter, has been an exercise that many people have contributed towards across the whole organization. That process and the development of a strategic workplan would not have been possible without Heidi Strunk’s and Will Benedict’s leadership, nor the dedication and work ethic of the QA, RA, and Operations teams and the many other people that stepped up to help. I do want to acknowledge and thank each of you for your tremendous and tireless contributions in navigating PTS through the response to the Warning Letter.

Congratulations and thank you.

Jonathan Chapman | President & CEO

2023 Company Holidays

  • Monday, January 2: New Year’s Day
  • Monday, May 29: Memorial Day
  • Tuesday, July 4: Independence Day
  • Monday, September 4: Labor Day
  • Thursday, November 23: Thanksgiving Day
  • Friday, November 24: Day After Thanksgiving
  • Monday, December 25: Christmas (1st Observed Day)
  • Tuesday, December 26: Day After Christmas (2nd Observed Day)

Please Welcome Our Summer 2023 Interns!

We are thrilled to have four interns with us this summer:

Claire Lu Headshot

Claire Liu:
Sustaining Scientist

Jennifer Quercioli Headshot

Jennifer Quercioli:
Sustaining Engineering

Jesse Crist headshot

Jesse Crist:
Manufacturing Engineering

Phillip Zirkle Headshot

Phillip Zirkle:
Manufacturing Engineering

Quarterly Question

Each quarter we ask PTS employees to participate in a fun question ranging in a variety of topics. This quarter we asked about things that we tend to be a little snobby about!

“What is something you are a little bit snobby about?”

 I’m a little bit snobby about my chosen sports teams; the Chicago White Sox and Notre Dame football.
Carolyn Schmitt, Regulatory Affairs

A good cup of coffee.
Kyle Nelson, Inside Sales

All-inclusive resorts. Just. No. I want to actually be able to go out and explore locally if I am flying out somewhere for my vacation.
Anushree Deshinge, Quality

Water. To me, different sources (bottled and tap) taste vastly different. If I have a choice, there are certain brands I prefer or at least filtered. If there are no other options around, I squeeze extra lemon in it to mask the flavor of dirt/metal/insert gross aftertaste here. 💧
Latasha Little, Marketing

Die Hard is a Christmas movie. I get into this argument with my wife all the time. What makes a Christmas Movie? Here’s the checklist:

  • Takes place during Christmas
  • Has Christmas music
  • Has a Christmas tree in it
  • Has Christmas presents
  • Has a Christmas party (work party @ Nakatomi Plaza)
  • Has a happy ending where the good guy ends up with his wife and kids for the holiday
  • And it snows

I mean, c’mon – Bad Santa gets a pass?
Jason Morrison, Finance

Butter not margarine or other spreads.
Gary Hughes, R&D

”The whole World calls “Football/Fútbol” while Americans call “Soccer.” When Americans call “football,” the sport only uses foot to kick the ball as kickoff, a field goal for 3-pts or an extra point. Are you “Fútbol or Soccer?” LOL
Annie VuMendoza, Quality

I’m a little bit snobby about apples. Don’t even try to hand me a Red Delicious. I will take it as a personal insult.
Andrea Sauceda, Marketing

McDonald’s Diet Coke is the BEST! Hotel Snob—No Super 8, Hotel 6 or Hotel with an External Room Entry Door for me!
Bridget Melland, Sales

Condiments/Sauces! I absolutely hate ALL condiments/sauces, except buffalo sauce.
Abbey Braasch, Human Resources

I am snobby about pop… I won’t touch a Pepsi product… I like coke. But I take it a bit farther and won’t touch diet pop either. Your brain doesn’t register the difference between diet pop and regular pop… they are both loaded with bad stuff, even though diet pop has less calories. So why bother with diet pop? Have the real thing and satisfy your craving for SUGAR!!!! You’ll drink less of the stuff.
Beth Russell, Sales

When the mailman or mailwoman “stuffs” my mail in the mail box… =(
Sarah Chavez, EHS

Things like sheets, pillows, toilet paper, paper towels, cell phones, etc. For things that you have to use on a daily basis, the quality of life benefits usually outweigh the extra expense.
Issa Emeish, Legal

Pie crust—it must be homemade, and made with lard.
Heidi Strunk, Quality and Regulatory

I am snobby about who has a cat as pet because I think cat is not loyal to the owners.
Jianwen Cai, Alignment Department

I don’t wear the same shirt in a month nor the same shoes twice in a row. (I get it from my mother)
Ashley Moses, Operations

A few imposter food items will NEVER live up to the original:

  • ”Breakfast” maple (corn) syrup < Pure Maple Syrup
  • Margarine < Butter
  • Miracle Whip < Mayonnaise
  • Skim Milk < Whole Milk
    George Spoerl, Ops Engineering

One thing I am snobby about is food made by others including friends, family and yes, colleagues. I have borderline germaphobia when it comes to food. Growing up, I observed questionable cooking etiquette courtesy of my grandmothers (and mother for that matter). Such etiquette traumatized me, leaving irreparable emotional scar tissue. Catered food or food ordered from a restaurant is fine, but when it comes to food from family, friends (or colleagues) my issues get the best of me. My wife will bring home homemade cookies from work or homemade leftovers when she visits her family, and when offered I decline. Next time there’s a pitch-in or chili cookoff, don’t take offense if I opt not to participate. I mean no harm. It’s just me being me, dealing with my emotional scar tissue.
— Jason Boesche, Operations

I am definitely Diet Coke-biased. If a restaurant only offers Pepsi products, I will typically ask for Diet Mountain Dew, or go with unsweet tea.
— Cameron Dobson, Marketing

I swear I can taste soap and the plastic in Tupperware after they’ve gone through any dishwasher (I’ve tried more than one). They’re ok for storing vegetables, but definitely not bread or any absorbing carb. I’ll eat a sandwich and can tell if the bread was stored in plastic. I also refuse to eat the Parmesan cheese that comes in the tall container! 😖
— Shelby Smiley, Quality

I am irritated when I listen to the morning traffic report (to decide what route to take to work) and the reporter references a crash at the intersection of two streets that don’t intersect (for example the intersection of Georgetown and Zionsville Roads!!). Also I hate it when they mispronounce and/or misspell road names. Thanks for letting me vent!
— Margo Enright, Regulatory Affairs

There are very things I am snobby about… but private label Q-Tips and Cheese Slices… ABSOLUTELY NO Kraft “fake” cheese… only real cheese.
— Gary Johnson, Sales

I’m a bit of a snob about brown eggs vs. white eggs, I have sworn since I was a little kid that brown eggs are saltier and yolkier and have better flavor. Whether that is true or not is irrelevant. But I’m a MAJOR snob about Cheez-Its vs. Cheese Nips, Goldfish or any other cheesy cracker. Cheez-Its or go home tbqh.
— Harley Howell, Customer Service

Finally was able to take a vacation in Italy with my wife!
Don Bellissimo, U.S. Sales

Class of 2023 Photos

Thank you for helping us celebrate!

Collage of graduates

Who's That Grad?

Think you know which of your coworkers were in the following graduation photos? Email Latasha with
your guesses and we’ll draw a winner with the most correct guesses to receive a gift card!

Collage of previous graduates

Do you have an idea for a future PTS Pulse newsletter story?

If so, submit to: [email protected]